Legislators
Denounce Leaked EPA Plan to Promote Human Pesticide Experiments(Beyond
Pesticides, January 25, 2006) On January 23, 2006, U.S.
Senator Barbara Boxer (D-CA), Rep. Henry A. Waxman (D-CA), and Rep.
Hilda L. Solis (D-CA) criticized EPA's Final Draft Rule on "Protections
for Subjects in Human Research," which they say promotes pesticide
experimentation upon humans. The rule was leaked to the legislators
by a concerned EPA official who requested that the original copy of
the plan not be duplicated in its entirety and widely distributed out
of concern for anonymity. According to the EPA's communications plan,
the Bush Administration will officially announce the pesticide experimentation
plan later this week as a final regulation.

In August 2005,
Congress enacted a moratorium upon EPA using human pesticide experiments
until ethical standards were established. Senator Boxer championed the
moratorium in the U.S. Senate. Representative Solis pushed the moratorium
through the U.S. House of Representatives. However, a contradicting
amendment on human pesticide testing sponsored by Senator Conrad Burns
(MT-R), also passed. The result was a compromised amendment that would
continue to allow human testing, but would force an end to EPA’s
stalled rulemaking process. The language of the conference committee’s
report sets a temporary ban on human pesticide testing that will last
until EPA implements the final version of the proposed rule.

"The Administration
plan is inconsistent with the law passed by Congress with bipartisan
support. The loopholes which allow continued testing on pregnant women,
infants and children are contrary to law and widely accepted ethical
guidelines, including the Nuremberg code. The fact that EPA allows pesticide
testing of any kind on the most vulnerable, including abused and neglected
children, is simply astonishing," said Senator Boxer.

"The regulation
is an open invitation to test pesticides on humans, which is the exact
opposite of what Congress intended," said Rep. Waxman. "The
Administration predicts that over 30 pesticide experiments will be submitted
to EPA each year under the new rule. That's an enormous step in the
wrong direction." If the rule is finalized as currently drafted,
it would apply to studies in which humans are intentionally dosed with
pesticides, as well as "observational" studies. According
to Representative Waxman, some of the serious flaws of the plan include
the following:

The Administration
plan is inconsistent with federal law. Congress required
that EPA ensure that pesticides are never tested upon pregnant women
and children. But the final rule would allow manufacturers to conduct
testing of pesticides upon both pregnant women and children so long
as there is no "intent" at the outset of the study to submit
the results to EPA. Additionally, the plan would allow pesticides
to be tested upon pregnant women and children in studies intended
for submission at exposure levels up to the current legal limits -
even though the National Academy of Sciences found that in some cases
this level of exposure could present acute risks to children.

The Administration
plan is inconsistent with the recommendations of the National Academy
of Sciences. Congress required that EPA establish a Human
Subjects Review Board (HSRB) as recommended by the National Academy
of Sciences. The Academy urged that this Board review research protocols
prior to consideration by an Independent Review Board (IRB). The Academy
expected that the HSRB would have ethical and pesticide expertise
that IRBs typically lack. This approach would allow an IRB to block
unethical research or require modifications suggested by the Human
Subjects Review Board prior to the initiation of a study. However,
the Administration plan would establish a powerless Human Subjects
Review Board that would consider research protocols after an IRB and
EPA staff had already approved a study. Under the Administration plan,
the HSRB would not have any authority to block or require modifications
to unethical research.

The Administration
plan would establish loopholes that could legally allow unethical
experiments.
The Administration plan introduces new loopholes that will allow for
ethical abuse. While the plan would require researchers to document
their ethical compliance in the United States when the plan applies
to them, it waives overseas researchers from having to prove a study
was ethically conducted - even when the researcher intends to submit
the study to EPA. Also, the plan would commendably subject EPA observational
studies to the Common Rule. However, observational studies conducted
by the pesticide industry would be bound by no specific ethical requirements.
These loopholes were never suggested or even contemplated by Congress.

"This is yet
another example of the Bush Administration choosing to ignore the letter
of the law and going its own way. Congress passed legislation to curb
the practice of unethical pesticide testing on humans, but with this
rule the Bush Administration is authorizing systematic testing of pesticides
on humans which not only fails to meet its congressional mandate but
which will increase the number of unethical studies," said Congresswoman
Solis. "Americans should be concerned about just how far the Bush
Administration will go to allow pesticide testing on pregnant women
and children and, the ease at which it chooses to ignore the law. The
Bush Administration must revise this rule to meet its Congressional
mandate and give Americans a policy which is moral, ethical, and safe."

"This rule
has not been signed by EPA Administrator Stephen Johnson yet. It's within
his power to fix this regulation, and we are calling on him to do so,"
said Senator Boxer.